Dose Response Study of Patients With Erythematous Rosacea

Erythematous (Type One) Rosacea Clinical Trial

Official title:

A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study of the Dose-Response Profile of V-101 Cream in Subjects With Erythematous Rosacea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01186068
• Other study ID #: V-101-ROSE-202
• Status: Completed
• Phase: Phase 2
• First received: August 17, 2010
• Last updated: November 22, 2010
• Start date: August 2010

Study information

• Verified date: August 2010
• Source: Vicept Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the dose-response relationship (effect) of four concentrations of V-101 Cream in patients with erythematous(redness) rosacea.

Description:

Patients must have moderate to severe erythematous (facial redness) rosacea

• Male and female patients must be at least 18 years old and in good general health

• Female patients must not be pregnant or nursing

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• male or females at least 18 years of age

• diagnosis of stable erythematous rosacea

• < 3 inflammatory lesions

• in good general health

• females must be non-pregnant and non-lactating

• must be willing to sign a consent form

Exclusion Criteria:

• have ocular, phymatous or other types of rosacea

• allergy to any ingredient in study drug

• participation in other investigational studies within 30 days of enrollment

• use of systemic steroids within 28 days of Baseline

• use of tetracycline antibiotics within 28 days of baseline

• use of products containing oxymetazoline within 14 days of baseline

• use of topical steroids witin treatment area 14 days prior to baseline

• use of Rx or OTC products for treatment of acne or rosacea within 14 days of baseline

• use of any product for reducing redness within the treatment area witin 14 days prior to baseline

• use of monoamine oxidase (MAO) inhibitors

• use of niacin >/= 500mg/day

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erythematous (Type One) Rosacea
• Rosacea

Intervention

Drug:
• V-101
Cream QD

Other:
• vehicle
Cream QD

Locations

Country	Name	City	State
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	DermResearch, Inc.	Austin	Texas
United States	DBA Michigan Center for Skin Care Research	Clinton Twp	Michigan
United States	Dermatology Specialists Research	Louisville	Kentucky
United States	Baumann Cosmetic & Research Institute	Miami Beach	Florida
United States	Oregon Medical Research Center, PC	Portland	Oregon
United States	Therapeutics Clinical Research	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Vicept Therapeutics, Inc.	Accenture

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician's Erythema Assessment	Physician visual evaluation	Day 28 visit	No
Secondary	Subject's Self Assessment	Patient assesses their condition	28 Day Visit	No